Efficacy and Safety of Zotarolimus-eluting Stent Overexpansion With OCT

Condition(s) studied

Investigational drug(s) / intervention(s)

Optical coherence tomography-guided percutaneous coronary intervention: OCT examination is performed using a frequency-domain OCT system (C7 Dragonfly OPTIS Imaging Catheter, Abbott Vascular, Santa Clara, CA, USA) with a 5.4 or 7.5 cm total pullback length according to a non-occlusive technique. The procedure is performed via radial or femoral access with a ≥6 Fr guiding catheter. The OCT catheter is advanced over the 0.014-inch PCI wire and the implanted stent was crossed after administration of intracoronary nitrates of 200 µg. For blood clearing, contrast media was injected through the guiding catheter with an automated power injector. The standard infusion rate was 4 mL/s for 4 seconds with 250 PSI. Follow-up OCT image acquisition was achieved with the same method. After post-PCI OCT, we evaluate the factor regarding post-PCI optimization target by European Expert Consensus.

Optical coherence tomography-guided Onyx family stent expansion: 1. Expansion of 2.25, 3.0, and 4.0 mm Onyx family stent@ nominal pressure 2. OCT pullback 3. Expansion with over 0.5mm sized non-compliant balloon of each stent 4. OCT pullback 5. Expansion with over 1.0mm sized non-compliant balloon of each stent 6. OCT pullback 7. Expansion with over 1.25\~1.5mm sized non-compliant balloon of each stent 8. OCT pullback 9. Evaluation of polymer status with overexpansion assessed by an electric microscope

Study summary

Investigators aimed to evaluate efficacy and safety of expansion capacity of zotarolimus-eluting Stent assessed by optical coherence tomography (OCT) in vivo study.

Eligibility

Primary outcome measure(s)

• Maximal stent overexpansion (%) — Through procedure completion, up to 24 hours
  defines as the ratio of the maximal stent diameter to each diameter of stent

Trial sites (1)

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